In 2023, 30 drugs with new active ingredients were introduced, including vaccines against the respiratory virus RSV and dengue fever as well as two gene therapy drugs. There were also 24 approval extensions, which expanded the area of application of drugs to additional diseases.
The 30 medications with new active ingredients that were introduced in Germany in 2023 are spread across the following disease areas:
- Cancers: 12
- Immunological diseases (autoimmune disease, allergic disease, congenital immune defects): 6
- Infectious diseases: 4
- Cardiovascular diseases: 2
- Bleeding diseases: 1
- Neurological diseases: 1
- Metabolic diseases: 1
- Other: 3
As in previous years, most of the newly approved drugs are directed against cancer: three against multiple myeloma (a form of bone marrow cancer), three for the diagnosis and treatment of prostate cancer and one against breast cancer. Three drugs are gene and cell therapies, bringing their total to 16. They can be used to treat rare diseases, including hemophilia (hemophilia A and now also B).
In addition, 24 already approved drugs were made applicable for other diseases, most of them against cancer and autoimmune diseases.
RSV vaccination protects babies and seniors
Two vaccines and an antibody drug against the respiratory syncytial virus (RSV) represent a particular success – this means that babies and people aged 60 and over can now be better protected. In addition, a vaccine against dengue fever is now available in Germany and is recommended by the Standing Vaccination Commission (STIKO) for people aged four and over who have already had an initial infection with dengue viruses.
However, the pharmaceutical industry is not satisfied because the GKV Financial Stabilization Act from 2022 changed the reimbursement system, so that the marketing of individual medications in Germany is not sufficiently profitable. That’s why pharmaceutical companies don’t bring them to market or withdraw them. This meant that significantly fewer drugs were approved last year than in 2021 and 2022 – there were 46 and 49 respectively.